Events

Recall of AFFINITY FUSION OXYGENATOR - OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC OF CANADA LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74855
  • Event Risk Class
    I
  • Event Initiated Date
    2017-01-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator. medtronic testing has not conclusively ruled out a potential impact of the flash therefore manufacturer is recalling the specific lots.

Device

AFFINITY FUSION OXYGENATOR - OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE
  • Model / Serial
    Model Catalog: BB811 (Lot serial: 13186543); Model Catalog: BB9G59R5 (Lot serial: 211991385); Model Catalog: BB841 (Lot serial: > 10 Lot Numbers contact mfg)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    AFFINITY FUSION OXYGENATOR - OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE;CUSTOM PACK W/BB COATING;AFFINITY FUSION OXYGENATOR - OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Manufacturer Address
    BRAMPTON
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC